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Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer
and leptomeningeal metastases

Primary: To determine the response of 2B3-101 treatment as single agent or in combination with trastuzumab in patients with LM from breast cancer using the LM response scoreSecundary: - To determine the safety profile in patients with LM treated…

Dexmedetomidine in awake implantation of neuromodulative systems.

The purpose of this study is to observe the usability of Dexmedetomidine and to determine the overall satisfaction of the patient.

Effect of bezafibrate on very long chain fatty acid (VLCFA) metabolism in men with X-linked adrenoleukodystrophy.

The trial is designed as an open-label pilot study. The main goal is to investigate if bezafibrate can reduce VLCFA in vivo in patient with X-ALD. If there is indeed a biochemical effect, a large follow-up study will be initiated with clinical…

Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain.
A multinational, multicenter, randomized, double blind, parallel groups, placebocontrolled
study.

Primary objective:To evaluate the efficacy of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain, when administered for 12 weeks including a 7-day titration period. Main secondary objectives:To evaluate pain…

The efficacy of the IDD-protocol with Accu-Spina for patients with low back pain

The primary objective of the study is to investigate whether the IDD (Intervertebral Differential Dynamics) protocol with Accu-Spina on the VAS low back pain score at 3 months posttreatment.

An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects WithNeuropathic Pain From Lumbosacral Radiculopathy

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.

Effect of GRAIL training in incomplete spinal cord injury

Both interventions (GRAIL training & endurance and strength training (control intervention)) will result in an increase in gait speed, functional walking ability and social participation. However, the GRAIL training will result in larger…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

The primary objective of the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.A secondary objective is to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain…

A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia)

The primary objective of this study is:* To assess the safety and tolerability of TPN-101 in patients with C9ORF72 ALS/FTDThe exploratory objectives of this study are:* To assess the concentrations of TPN-101 in plasma and cerebrospinal fluid (CSF…

An Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects with Neuromyelitis Optica Spectrum Disorder

This study has been transitioned to CTIS with ID 2023-510007-22-00 check the CTIS register for the current data. NMOSD is associated with a high degree of disability and mortality, and there is a unmet medical need in children with this disease.…

A multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group clinical trial to assess the efficacy and safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in patients with Post-Polio Syndrome

To test whether monthly infusions (every four weeks) of intravenous Flebogamma® 5% DIF in a 1 year treatment period in PPS subjects are superior to placebo by assessing physical performance, as measured by 2MWD.For Stage 1, to select the optimal…