Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

• Status: Completed
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess whether or not a single injection schedule of botulinum toxin A (BTX-A) in both hands improves Raynaud phenomenon (RP) secondary to systemic sclerosis (SSc) better than a placebo at 4, 12 and 24 weeks after the treatment.

This study's hypothesis is that the number of RP attacks per week from baseline to 4 weeks after treatment is significantly lower in the group treated with BTX-A than in the control group treated by the placebo. Furthermore, BTX-A in both hands is expected to improve both symptomatic (attack frequency, digital ulcer healing) and functional (pain, hand function, quality of life) symptoms of RP secondary to SSc more than placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; EMLA; Lidocaine; Nitrous Oxide; onabotulinumtoxinA; Pharmaceutical Solutions; Prilocaine

Criteria

Inclusion Criteria:

• Aged 18 years and older

• Diagnosed with systemic sclerosis (EULAR/ACR 2013 criteria ; or Leroy and Metsger criteria).

• Symptoms of Raynaud's phenomenon affecting both hands (not necessarily to equal extents)

• Frequency of Raynaud's attacks ≥ 5/week during cold weather

• Stable dose of phosphodiesterase inhibitors (sildenafil, tadalafil or vardenafil), endothelin antagonists, or calcium channel blockers defined as 1-month with no change in dose

• Ability to return/be available for follow-up evaluations

• Ability to fill the diary

• Ability/willingness to give informed consent

• Affiliation to any French social security regime

Exclusion Criteria:

• History of myasthenia gravis or Eaton Lambert syndrome

• Inflammatory myositis <2 years or pre-existing motor neurone disease or upper limb motor neuropathy

• Reported allergy or hypersensitivity to any Botulinum toxin preparation or to lidocaine or other local anesthetic agent or to albumin or to inhaled nitrous oxide/oxygen.

• Active infection in either hand.

• Pregnant or lactating women (women of child bearing potential must undergo a urine pregnancy teste before inclusion and at treatment day).

• women of child bearing potential without medically accepted method of birth control

• Patients who have previously undergone any vascular surgery on the upper extremity, including surgical sympathectomy or ever received botulinum toxin or planned to receive botulinum toxin in the next 6 months

• Cognitive impairment

• Iloprost scheduled the month following injections