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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With optional Open-label Extension

Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…

A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS)

Protocol version Amendment 1, 31-Jul-2015, paragraph 2.1, page 28:Primary objective:The primary objective is to assess the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.Secondary objectives:* Evaluation of…

Prevention of depression and poor physical function in older persons with vitamin D supplementation

Primary objectives: 1. Does vitamin D supplementation improve depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and functional limitations in older persons?Secondary objectives: 3. Does vitamin D…

A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.

Primary:The primary objective of the study is to evaluate the efficacy of oral administration of dexpramipexole 150 mg twice daily compared to placebo for 12 months in subjects with ALS.Secondary:The secondary objectives of the study are to evaluate…

A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients.

Primary Objective:To assess whether the clinical efficacy of RPC1063 is superior to interferon (IFN) *-1a (Avonex®) inreducing the rate of clinical relapses in patients with RMS.Secondary Objectives:- To assess the effect of RPC1063 on the…

Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS

The primary objective of this study is to confirm that levosimendan can significantly improve respiratory function measured by supine slow vital capacity (SVC) in amyotrophic lateral sclerosis (ALS) patients.The secondary objective is to confirm…

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis witching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

Part 1: The primary objective of this study is to evaluate the efficacy of natalizumab extended interval dosing (EID) in subjects who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to…

A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis

To assess the effect of treatment with 100 mg of FAB122 (edaravone) on disease progression in patients with ALS.

Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)

The primary objective of the study is:To assess the efficacy of TUDCA in slowing disease progression in patients with ALS during the treatment period compared to the lead-in phase), as measured by ALSFRS-R.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis.

This study has been transitioned to CTIS with ID 2023-508284-77-00 check the CTIS register for the current data. The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of gMG in adults with autoantibodies…

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)

Primary objective: To evaluate the effect of ravulizumab compared with placebo on amyotrophic lateral sclerosis functional rating scale-revised (ALSFRS-R) score in adult patients with amyotrophic lateral sclerosis (ALS).Secondary objectives:1. To…

A PHASE 3, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RELDESEMTIV IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)

The purpose of this study is to evaluate whether the new drug reldesemtiv is effective and safe in patients with ALS. The primary objective is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.The secondary objectives…

Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

Primary-Assess the efficacy of apitegromab compared with placebo using the HFMSE in patients 2 through 12 years oldKey secondary-Assess the efficacy of apitegromab compared with placebo based on the number of patients with clinical improvement in…

Withdrawal of Tiratricol Treatment in Males with Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency): A Double-blind, Randomized, Placebo-controlled Study

This study has been transitioned to CTIS with ID 2024-516124-34-00 check the CTIS register for the current data. Primary Objective:• To evaluate the effects of withdrawal of tiratricol treatment (placebo group) on serum total triiodothyronine (T3)…

A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS)

This study has been transitioned to CTIS with ID 2024-516559-41-00 check the CTIS register for the current data. To investigate the efficacy and safety of drugs for patients with ALS.

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to
Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of
Adult Patients with Amyotrophic Lateral Sclerosis (ALS)

This study has been transitioned to CTIS with ID 2023-508511-23-00 check the CTIS register for the current data. To assess safety and efficacy of AMX0035 for treatment of ALS.

Randomised double blind placebo controlled phase 3 trial of Triumeq in Amyotrophic Lateral Sclerosis (ALS)

This study has been transitioned to CTIS with ID 2024-517054-94-00 check the CTIS register for the current data. The primary objective of this study is to assess the efficacy of Triumeq versus placebo on overall survival, defined as death from any…

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in patients with gMG on stable background therapy. In addition, the study will assess the long-term safety and efficacy of…

A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)

The objective is to evaluate the efficacy and safety of two doses of masitinib (4.5 mg/kg/day and 6.0 mg/kg/day) versus matching placebo in patients diagnosed with ALS treated with Riluzole (50 mg bid).The primary objective is to demonstrate…

A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis.

To assess the effect of treatment with 100 mg of FAB122 (edaravone) on disease progression in patients with ALS.