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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 placebo-controlled double blind randomized trial to investigate the efficacy and safety of the combination of Penicillin G / Hydrocortisone treatment in ALS patients (PHALS).

The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

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…

Influenza vaccination in patients with Myasthenia Gravis

The main objective of this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG). The secondary objectives are to determine if vaccination…

A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness

Primary Objective:* To evaluate the safety and tolerability of ARGX-113.Secondary Objectives:* To evaluate the clinical effect of ARGX-113 using:-Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.-Quantitative-Myasthenia Gravis score (QMG…

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…

Effects of levosimendan on diaphragm contractility in healthy subjects

The primary objective of this proof of principle study is to determine the effect of levosimendan on the strength and endurance of the diaphragm in healthy subjects. The secondary objective is to gain insight in the neural activation and efficiency…

Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis

Primary: to assess the effect of intravenous (IV) ozanezumab (15 mg/kg once every 2 weeks) compared to placebo on the physical function and survival of ALS patients over a treatment period of 48-weeks.Secondary (major): other clinical outcomes,…

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 MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION

The primary objective of this trial will be to evaluate the effect of ONO-2506PO (1200 mg once daily) on the slope of respiratory function (slow vital capacity (SVC) expressed as a percentage of the predicted value) over 12 months compared with…

A randomised sequential trial of Lithium in amyotrophic lateral sclerosis

To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.

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…

A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of DNL104 in Healthy Subjects

- Investigate the safety and tolerability of single ascending doses of DNL104 in healthy volunteers.- Characterize the pharmacokinetics of DNL104 in plasma, CSF, and urine.- Characterize the effect of a high fat meal on the pharmacokinetics of…

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, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects with Amyotrophic Lateral Sclerosis

To evaluate the efficacy, safety, tolerability, in subjects with ALS following the oral administration of study drug (active or placebo capsules).

A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without PolyCAG Expansion in the ATXN2 Gene

Part 1: The primary objective is to evaluate the safety and tolerability of BIIB105 in participants with amyotrophic lateral sclerosis (ALS) or poly-CAG expansion (polyQ)-ALS.Part 2: The primary objective is to evaluate the long-term safety and…

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants with Amyotrophic Lateral Sclerosis

Primary• To investigate the safety and tolerability of multiple oral doses of DNL343 in participants with ALSSecondary• To characterize the PK of DNL343 in plasma following single and multiple oral doses• To characterize the concentration of DNL343…

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…