Randomised Placebo Controlled Trial of a Parenteral Modified Cobratoxin in Adrenomyeloneuropathy - Modified Cobratoxin Therapy in Adrenomyeloneuropathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002200-14-GB

Enrollment

Registered

2005-07-18

Start date

2006-10-17

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenomyeloneuropathy

Interventions

Product Name: modified cobratoxin Product Code: RPI78M for injection Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or Female Patients Diagnosed with Adrenomyeloneuropathy. Disability to cause difficulty with walking. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Asymptomatic Patients, Women of child-bearing potential.

Design outcomes

Primary

Measure	Time frame
Main Objective: This Study Aims to Assess the Safety and Efficacy of Modified Cobratoxin on the Motor Function in Patients with Symptomatic Adrenomyeloneuropathy.;Secondary Objective: Evoked responses, EDSS, SF-36 Quality of life.;Primary end point(s): Timed Walk (10M) and Ambulatory Score	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026