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Treat_CCM: Propranolol in Familial Cerebral Cavernous Malformation

Sponsored by Mario Negri Institute for Pharmacological Research

About this trial

Last updated 3 years ago

Study ID

IRFMN-7358

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

Cerebral Cavernous Malformation (CCM) is a cerebrovascular disease which can be either congenital in origin or sporadic and is characterized by the presence of isolated or multiple CCM lesions, causing recurrent headache, seizures, focal neurological deficits and hemorrhages. Inasmuch, to date, the only curative treatment available is limited to surgical lesion eradication or stereotactic radiosurgery. It is therefore necessary to find an effective medical treatment that may limit disease progression and decrease the burden of adverse clinical events. The non-selective betablocker propranolol has been found to be effective in the treatment of infantile cutaneous hemangioma, and anecdotal reports have been published on its efficacy in CCM. The safety profile of propranolol has been documented in millions of patients of all ages. The primary objective of this exploratory trial is to test whether a chronic treatment with propranolol will reduce the burden of cerebrovascular lesions, of clinical events and symptoms in patients with familial CCM.

What are the participation requirements?

Yes

Inclusion Criteria

1. Patients with Familial cerebral cavernous malformations (FCCM);

2. history of clinical symptoms or events: intracerebral hemorrhage, stroke, permanent or transient focal deficits, seizures, disability or any other neurological symptom supposedly related to CCM;

3. age of at least 18 years.

4. Written informed consent to participate in the study prior to any study procedures.

No

Exclusion Criteria

1. Implanted pacemaker or any other condition preventing the magnetic resonance imaging (MRI);

2. bradycardia (<50 bpm) or 2nd or 3rd degree AV block, hypotension (symptomatic);

3. unstable diabetes;

4. severe asthma;

5. renal and/or liver failure;

6. current use of verapamil and diltiazem for risk of excessive bradycardia;

7. previous brain surgery (within 6 months);

8. known hypersensitivity to study drug (propranolol or any of the ingredients)

9. pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception

10. participation to another clinical trial;

11. inability to cooperate with the trial procedures.